Medical Device Quality jobs

ABOUT 49North

49North is a Canadian defence company delivering secure, multi-domain C4ISR capabilities that provide decision advantage in complex and contested environments. A wholly-owned subsidiary of MDA Space, building on more than five decades of trusted Canadian defence delivery, 49North operates as a sovereign Canadian provider of mission-critical C4ISR systems, bringing disciplined prime-contractor execution to defence and security programs.

Visit 49North | An MDA Space Company (https://49northdefence.com/).

49North is rooted in the execution of large, complex, and mission-critical programs developed within 49NORTH. This legacy reflects a record of delivery where engineering rigour, operational reliability, and national trust are non-negotiable.

49North Defence strengthens Canada’s sovereign defence capability by delivering integrated mission systems and multi-domain C4ISR integration, enabling trusted Canadian and coalition operations, assured interoperability, and sustained readiness.

Role:

The QA-PA Lead/Member of Technical Staff reports to the Director, Mission Assurance of 49North. The role is responsible for providing direct support and guidance to business pursuits and program projects, maintaining and assuring conformity to 49North’s ISO 9001:2015 certified Quality Management System (QMS), and otherwise enabling company adherence to the Quality Policy.

Responsibilities:

Responsibilities fall under three key functions:

Programmatic Support and Independent Reporting

• Supports contract negotiations including identifying relevant quality-related clauses as applicable
• Estimates, prioritizes, plans and coordinates Quality/Product Assurance (QAPA) activities including tailoring standard processes as appropriate relative to pursuit or project needs. Defines corresponding work package(s) including specification of schedule and budget
• Authors detailed Quality Assurance Plans and ensures appropriate stakeholder involvement
• Provides QAPA leadership within pursuit/project and process execution contexts by engaging local leadership
• Acts as a quality liaison with corresponding external parties representing the customer or subcontractors/suppliers
• Reviews pursuit/project plans for conformance to the QMS; reviews other records and documentation, including that being provided to customers, and provides timely and meaningful feedback
• Plans, conducts and reports on project audits (including supplier/subcontractor audits) in accordance with the Universal Audit Schedule (UAS), sampling across processes and relative to established standards, contracts, plans and processes; completes audit plan and report content
• Leads and/or supports preparation for, conduct and followup of customer audit
• Manages subcontractor/supplier qualification by confirming relevant risks are identified and appropriately controlled and performance is monitored in accordance with plans and processes
• Identifies and initiates records of nonconformity when required, follows up on containment actions as necessary, facilitates determination of root cause(s), and establishes plans for resolution, and confirms completion of corrective actions. Updates and otherwise maintains supporting records
• Provides oversight of projects to ensure effective implementation of QMS requirements and participates in pursuit/project team meetings including risk reviews and significant milestone meetings
• Leads and/or facilitates the identification of lessons learned and tracks their realization as appropriate
• Represents QAPA interests in multi-stakeholder meetings including presenting information to customers and other interested parties and responding to related inquiries
• Elevates quality concerns among leadership and other stakeholders along the prescribed escalation path
• Performs status reporting as necessary including authoring content and presenting on specific topics.

Technical Solution Alignment

• Assures solution requirements are appropriately addressed in terms of elements of design, implementation deliverables and subsequent assembly, integration and test / verification and validation activities
• Assures the configuration of solution deliverables is sufficiently specified and controlled
• Works with project leadership and customer representation to establish that release criteria are prospectively defined and reflective of quality objectives to be achieved.
• Leads and/or supports the establishment and conduct of source or incoming inspections for materials or services that appropriately address quality requirements.
• Acts in the capacity of Manufacturing Quality Lead as a delegate of the Department Leader
  • Establishes the qualification of 49North facilities and contract manufacturers and their readiness to perform manufacturing for products where 49North holds design authority
  • Attends/hosts Manufacturing/Production Readiness Reviews to establish design transfer and corresponding production manufacturing capabilities as ready
  • Performs First Article Inspection (FAI) from bubbling of drawings to corresponding individual verifications being recorded and subsequent FAI Report finalization
  • Assures the appropriate inspection of parts and subassemblies relative to specifications confirming their suitability for use in production line assembly, integration and test (Production AIT or ‘light’ manufacturing) activities
  • Reviews manufacturing-related procedures and provides feedback from a quality management perspective
  • Affirms quality control activities (e.g. readiness, in-process and finished product inspections and checks) are completed according to defined practices and product meets corresponding specifications and quality objectives
  • Affirms equipment, tooling and workplace environments meet defined specifications and are maintained according to established process including e.g. calibration and electrostatic discharge management
  • Affirms the competency of personnel as sufficiently established to perform manufacturing and/or other Quality Control activities
  • Affirms matters of safety are sufficiently regarded within the manufacturing environment
  • Performs internal audits of program governing manufacturing activities and provides guidance and support to related 49North staff when implementing improvements or hosting external audits
• Confirms the work environment is sufficiently established to perform relevant activities (as applicable), including:
  • Equipment calibration and tool validation is established through available evidence.
  • Relevant environment parameters are established and maintained through monitoring, e.g. electrostatic discharge (ESD) controls, foreign object damage (FOD) controls
• Works with technical leadership to help define the inputs for integration activities and the applicable corresponding verification and validation activities
• Chairs and/or participates in Change Control Boards (CCBs) and Material Review Boards (MRBs) to confirm effective dispositioning of solution components for subsequent activities
• Leads and/or supports the conduct of independent test witnessing as required and performance of Test Readiness Reviews (TRRs) and Test Review Boards (TRBs).
• Reviews and approves technical documentation to confirm:
  • Requirements have been sufficiently addressed,
  • Identified risks have been adequately regarded,
  • Documentation provided is reasonably free of inconsistencies and discrepancies, and
  • Determinations made are adequately supported by evidence.

Quality System Maintenance and Support

• Plans, conducts and reports on system (i.e. process) audits in accordance with the audit schedule and relative to established standards, plans and processes; completes audit plan and report content
• Leads and/ or supports preparation for, conduct and followup of registration audits
• Maintains the integrity of the Approved Suppliers List
• Contributes to the continual improvement of 49North’s QMS including engaging in process improvement activities and performing (or supporting) process-related training
• Mentors colleagues in the conduct of QAPA activities and updates personnel development plans accordingly
• Provides functional supervision over assigned quality system topic areas to define and maintain consistency in practice and the data-driven determination of effectiveness
• Stays informed on QAPA best practices and applies new knowledge as appropriate within the current work context

Requirements (experience/skills)

• Post-secondary degree in Science or Engineering (or equivalent) and at least 3-5 years of relevant experience (level commensurate with experience).
• Two or more years of experience leading audits (level commensurate with experience); certification to ISO 9001:2015 (or another internationally recognized quality management system standard) as an internal auditor considered an asset.
• Experience working with ISO 9001:2015 (or equivalent, e.g. AS9100-D) requirements within the context of a company quality management system.
• Knowledge of the following standards considered an asset: ISO 14001 Environmental Management, ISO 45001 Occupational Health & Safety Management, and ISO 22301 Business Continuity Management
• Requires the ability to travel within and outside of Canada. Such travel is occasional only and typically addressed on an exception basis

General

• Requires excellent verbal, written and presentation communication skills
• Requires excellent time management and prioritization capabilities
• Requires the ability to manage office communication and collaboration computer applications
• Requires the ability to work well within a team and liaise with stakeholders at all levels of the organization

We’re a dream team of purpose-driven, collaborative and passionate people, and we are constantly looking for others to join 49North to ignite new and innovative approaches to problem-solving that push us forward.

Comments/Special Considerations:

Successful candidates must obtain and hold security clearance at the secret level, and pass security assessment for the Controlled Goods Program (CGP) and ITAR.

Benefits statement:

49North provides competitive compensation and benefits packages for its employees at all locations. As a team member of 49North, you and your qualified dependents are eligible to participate in a benefit plan that ensures a comprehensive level of protection through competitive health care including; extended healthcare and flexible drug plans, dental and vision benefits, disability income protection, life insurance, group retirement savings plans; and an employee and family assistance program.

Equal opportunity statement:

49North is an equal opportunity employer prizing diversity and inclusion. We are committed to treating all employees and applicants for employment with respect and dignity. If you require assistance and/or reasonable accommodation due to a disability during the application or the recruiting process, please feel free to notify us.

Accommodations

49North is proud to provide accommodation(s) during the recruitment process. Should you require any accommodations, please indicate this on your application/cover letter and we will work with you to meet your accessibility needs.

The compensation range for this position is ~$108,000.00 - $142,000.00 annually. The specific compensation offered will be based on the qualifications and experience of the successful candidate.

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